A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Cloth Reduces Infectious Morbidity in Patients Undergoing Cesarean Section

Purpose:

The objective of this study is to determine if the use of chlorhexidine gluconate cloths
prior to cesarean section reduce the rate of infectious morbidity (i.e. surgical site
infections, endometritis).
The study will be offered to women who present for a scheduled primary or repeat cesarean
section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2%
chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the
night before and the morning of their scheduled procedure. Participants will be blinded to
the arm in which they have been assigned. This study intends to show that the use of 2% CHG
cloths prior to cesarean section will reduce the rate of surgical site infections.

Study summary:

Chlorhexidine is a sterile, germ-free solution, which is regularly used to clean the skin
immediately before surgery and works by killing or preventing the growth or spread of
bacteria. Data exists in both the orthopedic and cardiac literature to show that an
additional preoperative use of chlorhexidine further reduces the risk of post procedure
infections. Limited data exists regarding the use of a preoperative use of chlorhexidine in
patients undergoing Obstetric or Gynecologic procedures and there is no wash or cloth used
prior to cesarean section as a standard of care. The hope for this study is to identify if an
additional preoperative chlorhexidine wash will further decrease or prevent infection in
women who deliver their babies via cesarean section.
All patients with a scheduled cesarean section surgery will be approached for enrollment
during their pre-admission testing visit on the labor floor 2 days before the scheduled
cesarean section, a visit that is standard procedure for this surgery. Once a patient is
consented, she will be randomly assigned to one of the 2 arms of the study: the eligible
women will be randomized to use of 2% chlorhexidine gluconate (CHG) cloths or placebo cloths
(a fragrance free cleansing cloths) on the body the night before and the morning of their
scheduled procedure. Participants will be blinded to the arm in which they have been
assigned.
The purpose of this study is to determine if the use of 2% chlorhexidine gluconate cloths
prior to cesarean section reduces the rate of surgical site wound infection and/or postpartum
endometritis, which is an infection or inflammation of the endometrium (the inner lining of
the uterus).